Kura Oncology Reports Second Quarter 2020 Financial Results
Kura Oncology Reports Second Quarter 2020 Financial Results
08-06-2020
– Anticipate preliminary data presentation of menin inhibitor program, KO-539, at ASH –
– Continued progress in registration-directed trial of tipifarnib in HRAS mutant HNSCC –
– Opportunity to expand to HRAS and PI3K dependent tumors with potential to target up to 50% of HNSCC –
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– Management to host webcast and conference call today at
“Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML),” said
Corporate Update
- Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the
American Society of Hematology Annual Meeting inDecember 2020 , and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.
- Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the
American Society of Clinical Oncology (ASCO) Virtual Scientific Program inMay 2020 . The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company’s efforts in HRAS mutant HNSCC, a disease of high unmet need.
- Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.
- Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.
Financial Results
- Research and development expenses for the second quarter of 2020 were
$13.7 million , compared to$11.4 million for the second quarter of 2019.
- General and administrative expenses for the second quarter of 2020 were
$7.5 million , compared to$4.5 million for the second quarter of 2019.
- Net loss for the second quarter of 2020 was
$20.5 million , compared to a net loss of$14.9 million for the second quarter of 2019.
- Cash, cash equivalents and short-term investments totaled
$338.9 million as ofJune 30, 2020 , including net proceeds of approximately$134.9 million from a public offering completed inMay 2020 , compared with$236.9 million as ofDecember 31, 2019 .
- Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.
Conference Call and Webcast
Kura’s management will host a webcast and conference call today at
About
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s product candidates, tipifarnib and KO-539, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, the strength of Kura’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, the risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the
| Statements of Operations Data | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 13,697 | $ | 11,440 | $ | 26,272 | $ | 21,822 | ||||||||
| General and administrative | 7,476 | 4,451 | 15,101 | 9,020 | ||||||||||||
| Total operating expenses | 21,173 | 15,891 | 41,373 | 30,842 | ||||||||||||
| Other income, net | 686 | 948 | 1,676 | 1,959 | ||||||||||||
| Net loss | $ | (20,487 | ) | $ | (14,943 | ) | $ | (39,697 | ) | $ | (28,883 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.38 | ) | $ | (0.82 | ) | $ | (0.75 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted |
51,633 | 38,928 | 48,522 | 38,550 | ||||||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| 2020 | 2019 | |||||||
| Cash, cash equivalents and short-term investments | $ | 338,869 | $ | 236,891 | ||||
| Working capital | 323,635 | 224,039 | ||||||
| Total assets | 353,000 | 241,972 | ||||||
| Long-term liabilities | 12,075 | 7,627 | ||||||
| Accumulated deficit | (252,574 | ) | (212,877 | ) | ||||
| Stockholders’ equity | 322,374 | 218,781 | ||||||
Contacts
Company:
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
pete@kuraoncology.com
Investors:
Managing Director
Westwicke ICR
(858) 356-5932
robert.uhl@westwicke.com
Media:
Managing Director
(619) 849-6005
jason@canalecomm.com
Source: Kura Oncology, Inc.